PainPhase 2ZIDONNCT00996983
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer
A Phase 2 study testing ziconotide in people with Pain and Neuropathic Pain, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Neuropathic Pain, Intractable Pain
- What is being tested?
- ziconotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2009to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of neoplasm
- Neuropathic pain level VASPI > or = 6 (0-10 scale)
- Inadequate pain relief with opioid analgesics and adjuvants
- Age > or = 18 years
- Performance status ECOG 0-2
- Life expectancy at least one month
- Adequate contraception in women of child-bearing potential
- Signed Informed Consent
Who cannot join
- Use of experimental drugs within previous 30 days
- Pregnancy or lactation
- Contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid
- Presence of cerebral metastasis
- INR > 2
- Contraindication to the use of ziconotide
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.
Read the detailed description
The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.
- Conditions
- Pain, Neuropathic Pain, Intractable Pain, Cancer
- Being tested
- ziconotide
- Medical subject headings
- Pain, Neuralgia, Pain, Intractable, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziconotideDrug
intrathecal ziconotide starting at 2.4 micrograms/day, with titration daily to achieve adequate pain control up to maximum dose of 21.6 micrograms/day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: ziconotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (> 30% reduction in VASPI)
Measured: 48 hours after completion of titration phase
Secondary outcomes (2)
toxicity
Measured: daily during drug titration, weekly thereafter
duration of analgesic response
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arturo Cuomo, M.D., Principal investigator, NCI Naples, Division of Pain TherapyGennaro Russo, M.D., Principal investigator, NCI Naples, Division of Pain TherapyAlessandro Morabito, M.D., Principal investigator, NCI Naples, Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996983
- Sponsor's protocol ID
- ZIDON
- Other IDs
- EudraCT number: 2008-005307-26
- Acronym
- ZIDON
- Status last verified
- Mar 2023
- First submitted
- 30 Sep 2009
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer
- ClinicalTrials.gov ID
- NCT00996983
- Acronym / sponsor ID
- ZIDON / ZIDON
- Conditions
- Pain, Neuropathic Pain, Intractable Pain, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.
Detailed description
The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ziconotide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of neoplasm
- Neuropathic pain level VASPI > or = 6 (0-10 scale)
- Inadequate pain relief with opioid analgesics and adjuvants
- Age > or = 18 years
- Performance status ECOG 0-2
Key exclusion criteria (7 listed)
- Use of experimental drugs within previous 30 days
- Pregnancy or lactation
- Contraindication to the use of intrathecal analgesics, including active infection or conditions that could alter the circulation of cerebrospinal fluid
- Presence of cerebral metastasis
- INR > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ziconotideintrathecal ziconotide starting at 2.4 micrograms/day, with titration daily to achieve adequate pain control up to maximum dose of 21.6 micrograms/day | Drug | A |
Primary outcome
Response rate (> 30% reduction in VASPI)
Time frame: 48 hours after completion of titration phase
2 secondary outcomes
toxicity
Time frame: daily during drug titration, weekly thereafter
duration of analgesic response
Time frame: weekly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Cuomo, M.D. principal investigator
NCI Naples, Division of Pain Therapy
Gennaro Russo, M.D. principal investigator
NCI Naples, Division of Pain Therapy
Alessandro Morabito, M.D. principal investigator
NCI Naples, Clinical Trials Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ziconotide in people with Pain and Neuropathic Pain, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (> 30% reduction in VASPI) (time frame: 48 hours after completion of titration phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.